Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

Exclusion Criteria

• •History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
• •History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
• •Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
• •Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
• •History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
• •Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
• •Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
• •Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
• •History of cancer;
• •History of drug abuse, judging by the investigator
• •History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
• •History of smoking
• •History of severe allergy / hypersensitivity, judged by the investigator;
• •History of hypersensitivity to drugs with similar chemical structure.